Medscand Pap-Perfect Supply Tray
- Primary DI
- 20888937009914
- Brand
- Medscand Pap-Perfect Supply Tray
- Company
- Coopersurgical, Inc.
- Model
- 60115-20/50
- Device description
- Cytobrush Plus GT
- Published
- 2016-09-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K832986 | 000 | PAP SMEAR BRUSH | Donald G. Zeller | 1984-02-10 | HHT |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20888937009914 | Package | GS1 | 20 | In Commercial Distribution |
| 60888937009912 | Primary | GS1 | 0 | |
| 00888937009910 | Unit of Use | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Papanicolaou smear kit | A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device. |
Regulatory Flags
- DUNS number
- 801895244
- Device count
- 50
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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